FDA批准口服避孕药Quartette

圣路易斯(MD Consult)——2013年3月29日，梯瓦制药宣布，美国食品药品管理局(FDA)已批准Quartette(左炔诺孕酮/乙炔雌二醇与乙炔雌二醇)片剂用于避孕。据梯瓦制药介绍，Quartette是下一代缓释口服避孕药的代表，其设计旨在尽可能减少2个规律月经周期之间的突破性出血(BTB)。

Quartette是一种独特的91天口服药物，在前84天中的3个时间点增加雌激素剂量，并使孕酮水平保持稳定，后7天则服用10 μg的乙炔雌二醇。

Quartette的获准是基于1、2和3期临床试验的安全性和有效性结果。在招募了3,000多名女性的3期临床试验中，Quartette被证明具有高达97%的避孕有效率。这项研究的数据还表明，最常见不良反应为头痛、严重/不规则阴道出血、恶心/呕吐、痤疮、痛经、体重增加、情绪改变、焦虑/惊恐发作、乳房疼痛和偏头痛。这项临床试验还评估了BTB的发生率，结果显示不规律月经的分布范围在连续91天疗程中缩小。

Quartette的标签警示信息指出，年龄大于35岁和吸烟的女性不可使用该产品，吸烟可增加与使用口服避孕药相关的严重心血管不良反应。应当告知女性患者，使用激素类避孕药与多种严重不良反应有关，包括血栓栓塞、卒中和心肌梗死。

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ST LOUIS (MD Consult) - On March 29, 2013, Teva Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. According to Teva, Quartette represents the next generation of extended regimen oral contraceptives, and was designed to minimize breakthrough bleeding (BTB) between scheduled periods.

Quartette features a unique 91-day oral regimen, whereby the dose of estrogen increases at 3 distinct points over the first 84 days and the amount of progestin remains consistent; this is followed by 7 days of 10 μg of ethinyl estradiol.

The approval of Quartette was granted on the basis of results from phase 1, 2, and 3 clinical trials designed to evaluate the product's safety and efficacy. In the phase 3 clinical trial, which involved more than 3,000 women, Quartette was noted to be 97% effective at preventing pregnancy. Data from this study also demonstrated that the most common adverse reactions were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight gain, mood changes, anxiety/panic attack, breast pain, and migraines. The primary clinical trial that evaluated the efficacy of Quartette also assessed the incidence of BTB. In that trial, unscheduled menstrual spotting decreased over successive 91-day cycles.

The Quartette label warns against use of the product by women who are older than 35 years and who smoke, and that smoking increases the risk of serious cardiovascular adverse effects associated with the use of oral contraceptives. Women should be told that the use of hormonal birth control is associated with increased risks of several serious adverse effects, including thromboembolism, stroke, and myocardial infarction.